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Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease

Primary Purpose

Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivipansel
Sponsored by
GlycoMimetics Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Anemia focused on measuring Rivipansel, GMI-1070, Selectin Inhibitor, SCD, VOC

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completion of Study B5201002.
  • Documented diagnosis of SCD.
  • At least 6 years of age.
  • Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.
  • Diagnosis of VOC necessitating IV opioids and admission to the hospital.
  • Able to receive the first dose of rivipansel within 24 hours from administration of the first dose of IV opioids for this hospitalization.

Exclusion Criteria:

  • Non-compliance with study procedures in the double blind study (B5201002).
  • Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
  • Clinically significant deterioration in renal function in Study B5201002.
  • Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
  • Active use of illicit drugs and/or alcohol dependence.

Sites / Locations

  • University of South Alabama Women's and Children's Hospital
  • Arkansas Children's Hospital Research Pharmacy
  • Arkansas Children's Hospital
  • UC Davis Medical Center Main Hospital
  • University of California Davis Medical Center
  • Howard University Center for Sickle Cell disease
  • MedStar Health Research Institute
  • Howard University Hospital
  • Golisano Childrens Hospital of Southwest Florida
  • Jackson Memorial Hospital
  • University of Miami
  • St. Mary's Medical Center
  • Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:
  • Grady Health System
  • Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:
  • Emory Children's Center
  • Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center/
  • Children's Healthcare of Atlanta: Scottish Rite Campus
  • Memorial Family Medicine Center
  • Memorial Health University Medical Center
  • The University of Chicago/Comer Children's Hospital
  • University of Chicago, Investigational Drug Service Pharmacy
  • University of Maryland Medical System Investigational Pharmacy
  • University of Maryland Medical System
  • Johns Hopkins Department of Medicine Clinical Trials Unit
  • The Johns Hopkins University School of Medicine
  • The Johns Hopkins Hospital Department of Pharmacy Services
  • Johns Hopkins Medicine
  • Boston Children's Hospital
  • Brigham and Women's Hospital
  • Center for Clinical Investigation, Brigham and Women's Hospital
  • Investigational Drug Services
  • Children's Hospital of Michigan
  • University of Mississippi Medical Center - Outpatient Clinical Research Unit
  • University of Mississippi Medical Center
  • Center for Outpatient Health
  • Barnes-Jewish Hospital Department of Pharmacy
  • Barnes-Jewish Hospital
  • Center for Advanced Medicine
  • Washington University School of Medicine
  • Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
  • Rutgers-Robert Wood Johnson Medical School
  • Rutgers Cancer Institute of New Jersey
  • Jacobi Medical Center
  • Kings County Hospital Center
  • State University of New York (SUNY) Downstate Medical Center
  • SUNY Downstate Medical Center University Hospital of Brooklyn
  • Columbia University Medical Center Research Pharmacy
  • MS CHONY Pediatric Emergency Department
  • MS CHONY Pediatric Hematology/Oncology Unit
  • Duke University Hospital, Investigational Drug Service
  • Duke University Medical Center
  • East Carolina University Brody School of Medicine
  • East Carolina University, Brody School of Medicine
  • Leo W. Jenkins Cancer Center
  • Vidant Medical Center
  • University of Cincinnati - Hoxworth Building
  • University of Cincinnati Medical Center / Investigational Pharmacy
  • University of Cincinnati Medical Center / Research Office
  • University of Cincinnati Medical Center
  • University of Cincinnati Physicians Company LLC
  • UC Health Ridgeway Hospital
  • The Ohio State University Investigational Drug Services
  • The Ohio State University Wexner Center East
  • The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute
  • The Ohio State University Wexner Medical Center
  • UPMC Presbyterian
  • UPMC Hillman Cancer Center
  • Hasbro Children's Hospital
  • Rhode Island Hospital-Pharmacy Service
  • Rhode Island Hospital
  • The Miriam Hospital
  • Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
  • Medical University of South Carolina-Hospital
  • Medical University of South Carolina
  • MUSC Investigational Drug Services
  • Cook Children's Hematology and Oncology Center
  • Cook Children's Medical Center
  • Cook Children's Hematology and Oncology Center-Grapevine
  • University of Texas Medical School
  • Primary Children's Hospital Laboratory
  • Primary Children's Hospital
  • Main Hospital-VCU
  • Virginia Commonwealth University - Investigational Drug Services
  • Virginia Commonwealth University- Clinical Research Services Unit
  • Royal Alexandra Hospital
  • Miseracordia Community Hospital
  • Kaye Edmonton Clinic 3C
  • University of Alberta Hospital, Pharmacy Services
  • Stollery Children's Hospital
  • University of Alberta Hospital
  • Research transition Facility
  • Grey Nuns Community Hospital
  • Children's Hospital of Eastern Ontario
  • The Hospital for Sick Children
  • Centre Hospitalier Universitaire Sainte-Justine
  • The Montreal Children's Hospital / McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Includes one adult stratum (>18 years old) and one pediatric stratum (12-17 years old). Subjects aged 12 and over who weigh >40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg.

Includes one pediatric stratum (6-11 years old). Subjects 6 to 11 years of age or subjects who weigh 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg).

Outcomes

Primary Outcome Measures

Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study.
Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study, number of TEAEs over the study and rate of TEAEs per subject per Vaso-Occlusive Crisis (VOC) will be summarized overall, by system organ class and by preferred term.
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study.
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study, number of events of adjudicated ACS and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study, number of events of adjudicated severe and/or generalized cutaneous manifestations and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Number (%) of subjects with serious adverse events (SAEs) over the study.
Number (%) of subjects with serious adverse events (SAEs) over the study, number of SAEs over the study and rate of SAEs per subject per VOC will be summarized overall, by system organ class and by preferred term.

Secondary Outcome Measures

Subject re hospitalization
Number (%) of subjects re hospitalized for VOC within 7, 14, and 30 days of most recent discharge will be provided overall. Number of re hospitalizations for VOC within 7, 14, and 30 days of most recent discharge and the rate of re hospitalization for VOC within 7, 14, and 30 days of most recent discharge per subject per VOC will be provided as well.

Full Information

First Posted
April 29, 2015
Last Updated
February 8, 2021
Sponsor
GlycoMimetics Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02433158
Brief Title
Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease
Official Title
An Open-Label Extension Study to Evaluate the Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
The B5201003 OLE study was terminated based on the failure of the 'parent" B5201002 study to meet its efficacy endpoints. Termination was not due to safety.
Study Start Date
December 16, 2015 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlycoMimetics Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).
Detailed Description
This is an open label extension study in subjects who are 6 years of age or older with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). This study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (VOC) events in hospitalized subjects with SCD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
Keywords
Rivipansel, GMI-1070, Selectin Inhibitor, SCD, VOC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Includes one adult stratum (>18 years old) and one pediatric stratum (12-17 years old). Subjects aged 12 and over who weigh >40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Includes one pediatric stratum (6-11 years old). Subjects 6 to 11 years of age or subjects who weigh 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg).
Intervention Type
Drug
Intervention Name(s)
Rivipansel
Other Intervention Name(s)
GMI-1070
Intervention Description
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.
Primary Outcome Measure Information:
Title
Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study.
Description
Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study, number of TEAEs over the study and rate of TEAEs per subject per Vaso-Occlusive Crisis (VOC) will be summarized overall, by system organ class and by preferred term.
Time Frame
18 months
Title
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study.
Description
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study, number of events of adjudicated ACS and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Time Frame
18 months
Title
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study
Description
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study, number of events of adjudicated severe and/or generalized cutaneous manifestations and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Time Frame
18 months
Title
Number (%) of subjects with serious adverse events (SAEs) over the study.
Description
Number (%) of subjects with serious adverse events (SAEs) over the study, number of SAEs over the study and rate of SAEs per subject per VOC will be summarized overall, by system organ class and by preferred term.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Subject re hospitalization
Description
Number (%) of subjects re hospitalized for VOC within 7, 14, and 30 days of most recent discharge will be provided overall. Number of re hospitalizations for VOC within 7, 14, and 30 days of most recent discharge and the rate of re hospitalization for VOC within 7, 14, and 30 days of most recent discharge per subject per VOC will be provided as well.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completion of Study B5201002. Documented diagnosis of SCD. At least 6 years of age. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. Diagnosis of VOC necessitating IV opioids and admission to the hospital. Able to receive the first dose of rivipansel within 24 hours from administration of the first dose of IV opioids for this hospitalization. Exclusion Criteria: Non-compliance with study procedures in the double blind study (B5201002). Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results. Clinically significant deterioration in renal function in Study B5201002. Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception. Active use of illicit drugs and/or alcohol dependence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Women's and Children's Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Arkansas Children's Hospital Research Pharmacy
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
UC Davis Medical Center Main Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Howard University Center for Sickle Cell disease
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Golisano Childrens Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center/
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Children's Healthcare of Atlanta: Scottish Rite Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Memorial Family Medicine Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
The University of Chicago/Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago, Investigational Drug Service Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Maryland Medical System Investigational Pharmacy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Department of Medicine Clinical Trials Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
The Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
The Johns Hopkins Hospital Department of Pharmacy Services
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-6180
Country
United States
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Center for Clinical Investigation, Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Investigational Drug Services
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Mississippi Medical Center - Outpatient Clinical Research Unit
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Center for Outpatient Health
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Barnes-Jewish Hospital Department of Pharmacy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
State University of New York (SUNY) Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
SUNY Downstate Medical Center University Hospital of Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Columbia University Medical Center Research Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
MS CHONY Pediatric Emergency Department
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
MS CHONY Pediatric Hematology/Oncology Unit
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Hospital, Investigational Drug Service
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
East Carolina University, Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Leo W. Jenkins Cancer Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
University of Cincinnati - Hoxworth Building
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center / Investigational Pharmacy
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center / Research Office
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Physicians Company LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
UC Health Ridgeway Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Ohio State University Investigational Drug Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
The Ohio State University Wexner Center East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Rhode Island Hospital-Pharmacy Service
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina-Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Investigational Drug Services
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Cook Children's Hematology and Oncology Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cook Children's Hematology and Oncology Center-Grapevine
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children's Hospital Laboratory
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Main Hospital-VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University - Investigational Drug Services
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University- Clinical Research Services Unit
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Miseracordia Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 4H5
Country
Canada
Facility Name
Kaye Edmonton Clinic 3C
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
University of Alberta Hospital, Pharmacy Services
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Research transition Facility
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2V2
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
The Montreal Children's Hospital / McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35981565
Citation
Dampier CD, Telen MJ, Wun T, Brown RC, Desai P, El Rassi F, Fuh B, Kanter J, Pastore Y, Rothman J, Taylor JG, Readett D, Sivamurthy KM, Tammara B, Tseng LJ, Lozier JN, Thackray H, Magnani JL, Hassell KL; RESET Investigators. A randomized clinical trial of the efficacy and safety of rivipansel for sickle cell vaso-occlusive crisis. Blood. 2023 Jan 12;141(2):168-179. doi: 10.1182/blood.2022015797.
Results Reference
derived

Learn more about this trial

Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease

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